American College of Cardiology

The Honorable June Gibbs Brown
Inspector General
Department of Health and Human Services
Office of Inspector General
Attention: OIG-7-CPG
Room 5246
Cohen Building
330 Independence Avenue, SW
Washington, D.C. 20201

RE: File Code: OIG-7-CPG; Office of Inspector General; Solicitation of Information and Recommendations for Developing OIG Compliance Program Guidance for Individual Physicians and Small Group Practices

Dear Ms. Brown:

The American College of Cardiology (ACC) is a 24,000-member non-profit professional medical society and teaching institution whose purpose is to foster optimal cardiovascular care and disease prevention through professional education, promotion of research, and leadership in the development of standards and formulation of health care policy. The College represents more than 90 percent of the cardiologists practicing in the United States.

We appreciate this opportunity to offer our comments on the Office of Inspector General's (OIG) solicitation of information and recommendations for developing OIG compliance program guidance for individual physicians and small group practices. While we appreciate the OIG's interest in providing iclear direction and assistance to physicians . . . who are interested in reducing and eliminating the potential for fraud and abuse within their practice,i we caution the OIG that there are other steps which both OIG and the Health Care Financing Administration (HCFA) must take to assist physicians and other providers who wish to reduce and eliminate fraud and abuse within Medicare and other Federal health care programs.

Such steps, discussed in more detail below, include the adoption of national payment policies, the elimination of contradictory language in the current coding and procedures manual, creation of educational programs to assist those involved in coding to be compliant, the creation of audit standards that clearly define the rationale used in determining medical necessity, and the fostering of a cooperative attitude towards physicians and providers in developing correct and appropriate coding.

These steps, taken together, would begin to go a long way to simplifying the myriad of laws, regulations, guidances, and other policies with which health care providers must comply. The ACC steadfastly believes that the vast majority of physicians and other health care providers wish to comply with the laws governing their participation in Medicare and other Federal health care programs, but compliance is made all but impossible by the shear number and complexity of those laws and regulations, not to mention the degree of latitude given the carriers and intermediaries in enforcement. As a practical matter, it may be impossible for any compliance program guidance to ensure that physicians and other providers are in compliance unless the OIG and HCFA to bring consistency to Medicare and other programs.

Finally, the seven elements that the OIG considers necessary for a comprehensive compliance program must be considered in light of the resources and capabilities available to individual physicians and small group practices. The designation of a compliance officer, for example, poses difficulties in a small or individual practice which may consist of as few as three persons. Since the compliance officer must be a person with a thorough understanding of the complexities of the fraud and abuse laws as well as the many rules and regulations relating to coding itself, most small practices would have to hire an additional person or send someone for extensive additional training. Each of these options would increase overhead expenses for the practice. Indeed, the OIG has recognized that implementation of a compliance program imay require significant additional resourcesi in previous compliance program guidance directed at other segments of the health care industry, such as third party medical billing companies. As such, we urge the OIG to make any compliance program guidance for individual physicians and small group practices as administratively simple as is possible.

In the pages that follow, we discuss each of these considerations in more detail. If you should have further questions on this issue, please contact the ACC's Regulatory and Legal Affairs staff at 800-435-9203. Thank you for your consideration of our comments on this important matter.

Sincerely,

Arthur Garson, Jr., M.D., M.P.H, F.A.C.C.
President

Comments to the Department of Health and Human Services'
Office of Inspector;
Solicitation of Information and Recommendations for Developing OIG Compliance Program Guidance for Individual Physicians and Small Group Practices;

File Code: OIG-7-CPG

Submitted by the American College of Cardiology

_________________________________

1. Implementation of an ieffective compliance programi may be prohibitively expensive. The expense of implementing a compliance program with all seven elements for a small group or single physician's practice is prohibitive n even the OIG has noted that implementation of ian effective compliance program requires a substantial commitment of time, energy and resources.i Furthermore, given that the OIG has admonished that i[s]uperficial programs that simply purport to comply with the [seven] elements . . . or programs hastily constructed and implemented without appropriate ongoing monitoring will likely be ineffective and could expose [the provider] to greater liability than no program at all,i we urge the OIG to consider the actual resources and capabilities of individual physicians and small group practices when designing its compliance program guidance.

   Recommendations:

   (a) The OIG must provide detailed and specific direction for individual physicians and small group practices that can be easily and efficiently tailored to their practices. Unlike the targets of previous guidances issued by the OIG, individual physicians and small group practices do not have the resources, either in staff or dollars, to pour into a compliance program. The OIG should make clear what it expects in as much detail as is possible.

   (b) The OIG should inform physicians of methods for staying abreast of fraud and abuse activities. Educational programs, software, and other methods of informing physicians of fraud and abuse activities and methods of complying with the myriad of complex laws and regulations should be made available and the OIG should inform physicians of how to incorporate these programs into their compliance programs.

2. There are steps that the OIG and HCFA can take to make compliance easier for physicians and other providers. Physicians and other providers that participate in Medicare and other Federal health care programs must comply with a myriad of laws, regulations, guidance documents, and other statements of policy and procedure. In some instances, Congress authors complex legislation that becomes law before the Administration has promulgated implementing regulations, allowing for much ambiguity in the interpretation and enforcement of the law by lower level entities within the Administration. This only adds to the lack of clarity which makes compliance difficult.

   Recommendations:

   (a) The implementation of national payment policies, written in language that is specific enough to minimize or prohibit contractor interpretation. Added to the complexity of the laws and regulations with which physicians must comply is contractor interpretation. In some instances, the same Medicare carrier may have different payment policies for two different states. This type of inconsistency leads to significant confusion, making compliance all the more difficult.

   (b) HCFA-approved coding courses designed to produce graduates that can understand and apply the complex Medicare coding and billing policies, as well as HCFA-approved continuing education for billers/coders and physicians and their staff. Most coders learn through on-the-job training, which is only as good as the original staff providing the training and the staff at the insurer (commercial or government) with whom they interact.

   At present, we are not aware of any HCFA-approved commercial consulting groups that offer advice on billing, coding, and documentation and the HCFA-approved online courses in fraud and abuse, diagnosis and procedure coding, and evaluation and management documentation are brief and very general in scope. The course materials do not address the complex issues of contractor-specific payment policies, such as local medical review policies, or contractor-specific claims submission policies, for example. Furthermore, most Medicare contractors do not offer classes in any of these areas that address their specific expectations and audit standards. Finally, information on billing and coding is not given much emphasis in the training of physicians and nurses.

   (c) HCFA should approve national Medicare/Medicaid audit standards, including standard audit workpapers and supplementary audit criteria, that clearly define the rationale used in determining medical necessity. As above, there is no uniformity in the implementation of these policies at a national level.

   (d) Both HCFA and the OIG should immediately seek to move to a cooperative relationship with providers rather than the current adversarial relationship that has developed. Like HCFA and the OIG, physicians wish to reduce wasteful fraud and abuse in Medicare and other Federal health care programs. We are concerned, however, that many of the initiatives undertaken by HCFA and the OIG to achieve that end are needlessly overzealous and threaten to punish physicians and other providers for honest billing mistakes. Furthermore, some of these initiatives threaten to interfere with the doctor-patient relationship by creating an atmosphere of mistrust between a physician and his or her patient. Implementing some of these changes would begin to change the atmosphere that exists between HCFA and the OIG and physicians.